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Antibiotic

Antibiotics for Cat Bite Injuries (CATBITE Trial)

Phase 4

Recruiting

Led By Kevin M Klifto, DO, PharmD

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2; day 7+/-2; day 14+/-2; day 30+/-2

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial investigates duration of prophylactic antibiotics & placebo control for cat bites to the hand/forearm to reduce incidence of infection.

Who is the study for?

Adults over 18 who've been bitten by a cat on the hand or forearm within the last 24 hours can join this trial. They must speak English and be willing to take medication and attend follow-ups. Excluded are those with active infections, recent antibiotic use, immunodeficiencies, certain chronic diseases, fever above 100.4°F, pregnancy, malnutrition or hypersensitivity to study drugs.

What is being tested?

The CATBITE trial is testing if antibiotics prevent infection after a cat bite to the hand/forearm. Participants will randomly receive either a placebo; amoxicillin-clavulanate for one day; or amoxicillin-clavulanate for five days. The study will monitor infection development and assess disability and quality of life through questionnaires.

What are the potential side effects?

Possible side effects from antibiotics may include digestive issues like diarrhea or nausea, allergic reactions such as rashes or itching, and rarely more serious effects like severe intestinal conditions (C.difficile) or anaphylaxis in case of allergy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2; day 7+/-2; day 14+/-2; day 30+/-2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2; day 7+/-2; day 14+/-2; day 30+/-2

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2; day 7+/-2; day 14+/-2; day 30+/-2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes of the incidence of infection

Incidence of infection

Secondary study objectives

Adverse effects

Changes in HAND Questionnaire (HAND-Q) scores

Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores

+3 more

Other study objectives

Changes in location of cat bites that result in infection

Location of cat bites that result in infection

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Antibiotic x 1 dayActive Control5 Interventions

Amoxicillin-clavulanate 875-125mg capsules by mouth twice daily x 1 day (4 days of placebo capsules) -Penicillin allergy: ciprofloxacin 500mg by mouth twice daily + clindamycin 300mg by mouth three times daily x 1 day

Group II: Antibiotic x 5 daysActive Control4 Interventions

Amoxicillin-clavulanate 875-125mg capsules by mouth twice daily x 5 days (0 days of placebo capsules) -Penicillin allergy: ciprofloxacin 500mg by mouth twice daily + clindamycin 300mg by mouth three times daily x 5 days

Group III: Placebo (microcrystalline cellulose)Placebo Group2 Interventions

Placebo capsules by mouth twice daily x 5 days (5 days of placebo microcrystalline cellulose capsules)

Do I qualify?Apply below to find out